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Fspx Cra Ii (changsha), Shanghai

发表 2024-07-10
过期 2024-07-16
ID #2236568828
Fspx Cra Ii (changsha), Shanghai
China, 上海, 上海,
发表 July 10, 2024


As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Essential Job duties1) The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.2) Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned3) Responsible for all aspects of site management as prescribed in the project plans4) General On-Site Monitoring Responsibilities5) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study6) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review8) Monitor data for missing or implausible data9) Ensure the resources of the Sponsor and Company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Company travel policy10) Ensure audit readiness at the site level11) Travel, including air travel, may be required and is an essential function of the job.12) Prepare accurate and timely trip reports13) Responsible for all aspects of registry management as prescribed in the project plans14) Undertake feasibility work when requested15) Participate in and follow up on Quality Control Visits (QC) when requested16) Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor17) Might be requested to work in a client facing environment18) Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE19) Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management20) Assist with training, of new employees, e.g.

co-monitoring21) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned22) Perform other duties as assigned by management Experience Minimum required:• At minimum of 1(One) year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted• Ability to monitor study sites independently according to protocol monitoring guidelines, SOP and local regulatory Guidelines• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs• Good planning, organization and problem solving skills• Ability to work with minimal supervision• Good communication and interpersonal skills• Good analytical and negotiation skills• Computer competency• Fluent in local office language and in English, both written and verbal• Works efficiently and effectively in a matrix environment Education/Qualifications/Certifications and Licenses Minimum Required: • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

An equivalent amount of experience can be substituted as appropriate.• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirement• Thorough knowledge of monitoring procedures• Basic understanding of the clinical trial process• Valid Driver’s License Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.


工作类型: 全职
合同类型: 永恒的
薪酬类型: 每月
职业: Fspx cra ii (changsha)

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